Medical Consortium for Screening Upper Gastrointestinal Cancers With Magnetically Controlled Capsule Gastroscopy

July 24, 2019 updated by: Yanqing Li
The aim of our study was to demonstrate the efficacy and feasibility of the medical consortium for screening upper gastrointestinal cancers with magnetically controlled capsule gastroscopy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

In this study, the investigators designed a propective cohort study to evaluate the the efficacy and feasibility of medical consortium for screening upper gastrointestinal cancers (MCSC) with magnetically controlled capsule gastroscopy (MCCG).

Study Type

Interventional

Enrollment (Anticipated)

10000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Department of Gastroenterology, Qilu Hospital, Shandong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • asymptomatic subjects undergong magnetically controlled capsule gastroscopy for health checkup in medical consotium;
  • subjects able to give informed consent

Exclusion Criteria:

  • suspected or known intestinal stenosis, obstruction, or fistula;
  • inoperability of refusal to accept any abdominal surgery;
  • dysphagia or gastric paralysis;
  • previous history of gastrointestinal disease;
  • with pacemaker, implanted-cardiac defibrillator or other implanted electromedical devices;
  • need for standard magnetic resonance imaging examination within seven days after swallowing the MCCG, unless the capsule is confirmed to have been excreted;
  • other factors that are not suitable for inclusion evaluated by medical stuff

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Medical Consortium
subjects involved in medical consortium for screening upper gastrointestinal canccers(MCSC)
Other: Medical Consortium
subjects received intensive follow-up by coordinators according to the predifined protocol of MCSC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the incidence of upper gastrointestinal cancers, including gastric cancer and esophageal cancer.
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
tthe focal lesions of upper gastrointestinal tract
Time Frame: 12 months
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
adverse events
Time Frame: 12 months
safety assessment
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yanqing Li

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 31, 2018

Primary Completion (Anticipated)

December 31, 2019

Study Completion (Anticipated)

March 1, 2020

Study Registration Dates

First Submitted

July 23, 2019

First Submitted That Met QC Criteria

July 24, 2019

First Posted (Actual)

July 25, 2019

Study Record Updates

Last Update Posted (Actual)

July 25, 2019

Last Update Submitted That Met QC Criteria

July 24, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019SDU-QILU-150

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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